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About
The purpose of this study is to evaluate three things. The first being whether azacitidine is absorbed in the body at the same rate or proportion for different concentrations. The second is to determine the effect renal impairment has or does not have on the absorption of azacitidine. The third is to determine if azacitidine is safe and well tolerated in patients with renal function impairment.
Enrollment
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Inclusion criteria
Diagnosis of one of the following:
Patients with a history of treated brain metastases should be clinically stable for greater than 4 weeks prior to signing the informed consent form and off glucocorticoid therapy for central nervous system (CNS) edema for at least 4 weeks
Be capable of giving informed consent
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Have a life expectancy ≥ 3 months
Have stable renal function for at least 2 months
Have average calculated creatinine clearance of:
Have organ and marrow function at the screening and pre-dose visits as defined below:
Have a 12-lead electrocardiogram (ECG) that is not clinically significant, as determined by the Investigator, at screening
Have serum bicarbonate:
Women of childbearing potential may participate, providing are not pregnant and agree to use at least 2 effective contraceptive methods throughout the study
Males with a female partner of childbearing potential must agree to use at least 2 effective contraceptive methods throughout the study and to avoid fathering a child for 6 months following the date of the last dose of study medication
Be a nonsmoker or must not have smoked for at least 30 days before the screening visit and agree to abstain from smoking during study participation
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
31 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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